SMART-TRIAL Blog

White Paper: Navigating the EU Medical Device Regulation (MDR)

In April 2018, we hosted a scientific seminar for professionals in the medical device industry in Israel – ‘Navigating the New MDR – Strategies for Success’. To summarize the valuable information presented at the seminar we have authored an 8-page white paper. You can find a link to download your copy of the white paper at the bottom of this blog post. Below we highlight the important takeaways from the white paper.

White Paper Highlights

With continuous advancements in technology, more medical devices are being developed. Though new and innovative devices can transform healthcare, there’s a growing need to regulate the Medtech industry. First of all, to protect the patients, and second, to leverage its full potential.

The new European Union Medical Device Regulation (EU MDR) brings a wider and clearer regulatory scope. This enforces stricter requirements on manufacturers and notified bodies. Also, it brings new challenges in achieving regulatory compliance. But it comes with a more effective path to reach a common goal – ‘A safer healthcare ecosystem’.

How does this impact Medical Device Manufacturers?

The new MDR will both repeal and amend a few existing EU directives and regulations. The EU MDR states that there’s “no grandfathering” allowed. Manufacturers with products on the market will have to re-certify all of their devices. Available compliance documents will have to be tested against the new MDR/IVDR requirements.

The Most Notable Changes

It will be difficult to state how each article will be supervised in different member states and by notified bodies. But approaching the first date of application, we can expect guidance documents from industry leaders and authorized representatives (AR). Other notable changes include:

Wider and clearer scope for EU legislation e.g. include implants for aesthetic purposes

Stronger supervision of assessment bodies by national authorities

More power to assessment bodies to ensure regular checks on manufacturers and unannounced factory inspection

The Importance of Clinical Evaluation and Data

It was common practice to refer to an equivalent (predicate) medical device and its scientific data, to document clinical effectiveness. Now, the MDR is forcing all manufacturers to document their own device effectiveness, safety, and usability. Due to which, manufacturers will now have to collect and manage their clinical evidence and continuously check their clinical evaluation. This will drive the path to more transparency, but also force manufacturers to further optimize their clinical evaluation activities.

‘Evidence whether or not it’s clinically related is the gold of any Medical Device and should be treated as such’

The New MDR Driving ‘A safer healthcare ecosystem’

The steep road toward compliance with the new MDR requires planning. By analyzing the requirements and dividing the required resources, manufacturers will e.g. have to review:

The clinical and performance evaluation data – e.g. consider a postmarket clinical follow-up (PMCF) trials also for old products

Liability of the manufacturer and review corporate liability cover

Device classification

Finally, this blog post has only highlighted a fraction of the content in the white paper. To read more, you can request your own free copy by clicking the button below.

About The Author: Erika Pinto

Erika is SMART-TRIAL's leading market analyst and her focus is to share SMART-TRIAL's vision with MedTech and research organisations around the world. She has a Master's degree in Business Administration and IT from Copenhagen Business School.